Z-2324-2025Class III

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Name: Z-2324-2025 Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Creator: Diversatek Healthcare
Published: 2025-06-04
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2025-06-04 / Open, Classified / root cause: labeling and UDI

FDA source

Diversatek Healthcare began a recall of Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 on 2025-06-04. FDA classified it as Class III and gives the reason as "Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2324-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-06-04
Posted: 2025-08-14
Recalling firm: Diversatek Healthcare Inc
Product: Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following: Check your inventory for devices with the part and lot numbers listed below. 2. Discard any affected product. 3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to [email protected] If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408
Quantity in commerce: 8
Distribution: Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Product codes and lots: UDI-DI: 00816734022863, Lot: 24752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2324-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2324-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-14

Product code FFX

K190208Class IIDiversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare / cleared 2019-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)